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Vioxx has been voluntarily withdrawn

Posted by Kathy G on 9/30/04 at 09:05 (160742)

For those of you who might miss it, Vioxx has been taken off the world market by Merck after a three-year study showed that it significantly increased the risk of heart attack or stroke. The risk increased after the first eighteen months the patient took it. I would supply a link but the websites are so busy, it's hard to get connected.

For those of you on it, you should call your doctor and see what he suggests as an option. For me, Celebrex gave me one of the worst headaches I've ever had in my life, both times I tried it. I've been on Vioxx since 1999. I should keel over any day now! No smiley faces for me to click on but that's a joke!

Bextra is also an alternative as are Naproxen and all the other oldies. Your doctor will know.

I'm sure you're all going to hear it but I just wanted to give you a heads up. Remember, your pharmacies will have trouble supplying the alternates for a while, so if you really need it, call your doctor today so you'll be one of the first to get a prescription for an alternate drug.

And let's all pray our 401K's didn't invest heavily in Pfizer stock!

I posted this on the Treatments board, too. I was just thinking that most people who post on these boards are very well informed and probably know this but it doesn't hurt to reiterate.

Re: Vioxx has been voluntarily withdrawn

Pauline on 9/30/04 at 09:09 (160743)

Good to bring this to everyone's attention. I mean the drug not the stock of course.

Re: And I meant Merck stock, not Pfizer! nm

Kathy G on 9/30/04 at 09:40 (160747)



Re: And I meant Merck stock, not Pfizer! nm

john h on 9/30/04 at 09:51 (160751)

This morning it was announced there is a total recall on VIOXX because it may cause heart problems. I think this is the biggest product in the manufacturers inventory. I always thought that Vioxx and Celebrex were very close in composition. Wonder if Celebrex could be next????

Re: Vioxx has been voluntarily withdrawn

john h on 9/30/04 at 09:55 (160753)

Somewhere along the way I think I read that just good old aspirin is as effective as Vioxx or Celebrex. You just have to take more and may have stomach problems. There are still millions and millions on the enteric coated aspirin who have been on it for decades. We sometimes look over what is in front of our face because it is so easy to get.

Re: News Story Link

Richard, C.Ped on 9/30/04 at 10:01 (160756)

http://www.cbsnews.com/stories/2004/08/26/health/main638721.shtml

Re: And I meant Merck stock, not Pfizer! nm

Ed Davis. DPM on 9/30/04 at 10:06 (160757)

John:
Celebrex and Bextra, the competitors to Vioxx have a somewhat different chemical composition. Unfortunately, people allergic to Sulfa drugs, which is quite a few, cannot take Celebrex and Bextra so we are down to Zero for those people. I am not convinced of the dangers of Vioxx based on current information but wonder if this has occurred only in the uS or if it has occurred in other countries. There are too many unanswered questions but this perhaps could constitute a temporary action until those questions are resolved and further studies done.
Ed

Re: Merck press release

Ed Davis. DPM on 9/30/04 at 10:17 (160758)

http://www.vioxx.com/rofecoxib/vioxx/index.jsp

If you sit down with the evidence it is inconclusive, particularly when looking at all the studies. Based on available information, I would have not taken this drastic step but would have restricted Vioxx to short term use only. The alternatives, unfortunately, have their own lists of problems which, at times, can be much worse than the issues surrounding Vioxx. I am very curious to see how other countries interpret the action and the data.
Ed

Re: And I meant Merck stock, not Pfizer! nm

Ed Davis. DPM on 9/30/04 at 10:29 (160759)

John:
Celebrex was not quite exposed to the same level of scrutiny as Vioxx so it is a hard call. One good thing you can say about Merck is that they really do a lot of studies and, this time, may have shot themselves in the foot. They probably needed to include Celebrex in that study but the study can be come huge. The thing to remember is that Cox-2 inhibitors are not blood thinners like other anti-inflammatories. Here is a simple question:
If one re-did the study that implicated Vioxx but added 81 mg. of aspirin (baby aspirin) would the outcomes have been different. Unfortunately, it may take years to find out. If one takes a 'classical' anit-inflammatory, one is getting a blood thinning effect which may serve to be somewhat protective against cardiovascular events. The problem is that those drugs are very hard on the gut -- we spend billions per year just rtying to fix the gastrointestinal problems those other drugs cause.

I remain unconvinced that the action was better than restiricting Vioxx to short term use, based on the totality of the evidence and the alternatives.
Ed

Re: Time to invest

Richard, C.Ped on 9/30/04 at 10:45 (160761)

This actually might be a good time to invest in Merck stock. prices are low, and when things get back to normal, will go up again.
Hmmmmmm.

Re: Time to invest -

Kathy G on 9/30/04 at 11:44 (160765)

Richard,

My daughter wants to become a pharmaceutical rep. A friend just gave her the name of a Merck rep who said he would be glad to help her all he could. She emailed him twice in the last ten days and he hasn't responded. I suspect the company has been in an upheaval.

You're right. Aside from the medical implications, which are huge, the financial ramifications are unbelievable.

Astra-Zeneca bought out Bayer and is firing all the Bayer reps. Another major drug company, the name of which I can't recall, laid off 50% of its sales staff this week. Now this. Maybe she should consider another career!

Re: Merck press release

Kathy G on 9/30/04 at 12:05 (160767)

Ed,

I can't get to the link. My computer keeps freezing up. I suspect it's due to high volume. I will be very interested in reading the results of the actual study. I do know that the last one, last month, was definitely flawed. It said that people who took Vioxx were at risk of suffering a heart attack but when you read it, it was talking about much higher doses of Vioxx than are normally prescribed. Interestingly, the damage always took place in the early stages of taking the drug. This study says that there is no increase in cardiac events during the first eighteen months on the drug. That's totally contradictory to the first study.

Last week, I went to my rheumatologist, who ironically, prefers Celebrex to Vioxx, and he and I were talking about the results of the study of last month and he said that none of his colleagues were paying any attention to it because it was so flawed.

You have to think, however, that if the company pulled a drug that millions of people take, there has to be something to this study. Merck has the reputation of being one of the more responsible drug companies and has always put patient safety first, unlike some of the others. I wonder if it had been a less responsible firm, would it have withdrawn the drug or just put warning labels on it?

Interestingly, there have been no studies lasting longer than a year on Celebrex or Bextra. It makes me wonder what those might show up. Pfizer sure isn't going to run right out and start such a study voluntarily but I wonder if the FDA will require them to do so. Or can they, now that those drugs are on the market?

As for me, I'm sunk. I can't take any of the NSAID's because of my stomach and quite frankly, until I read more, I wonder if I should even start on Bextra. I suspect that Celebrex would still give me a headache. Headache is not listed as a side effect in the literature, by the way, but I wasn't going to make my doctor make out all the paperwork that goes with reporting it to the company. I already take a low-dose enteric coated aspirin and for the time being, I'll just take one extra. Or maybe I'll stay on the Vioxx for a while longer and wait until the dust settles. I've been taking it for five years with no ill effects. One thing for sure - I don't want to call my doctor about this for the next week or so. They must be going crazy with telephone calls.

Re: Merck press release

Ed Davis, DPM on 9/30/04 at 15:06 (160780)

Kathy:

My wife Ginni took Vioxx after her back surgery. I take it when my back aches. Based on the totality of information, its danger is not compelling especially when you consider the alternatives. You are absolutely correct in that WHO is going to compell the manufacturer of Celebrex and Bextra to do the same studies?

If I was taking Vioxx on a long term basis (you probably cannot now) this is what I, personally, would do. I would attempt to take an 81 mg. baby aspirin with food daily (if not tolerable then 2 to 3 times a week), I would up my vitamin E to 1600 mg. per day and take about 60 to 100 mg. of coenzyme q-10 per day, preferrably in divided doses. If I did so, I would not lose a minute's worth of sleep over Vioxx.

Do focus on nutrition. Doctors won't help you with this. Make sure that, now, you are taking Omega-3 supplements at least 3 times a day (about 1 to 2 grams three times a day). Take Bromelain supplements with each meal. Scott does mention that in the Heel Pain Book. It is an enzyme with antiinflammatory properties. Also, use topical ibuprofen gel (Ibugel) and others as liberally and frequently as you wnat on sore spots because it is virtually impossible to absorb too much.

I have a number of patients whom have had gastric bypasses. I have a compounding pharmacy place Celebrex in suppositories and get great results. Why Celebrex? Because I want the patient only to have to use the suppositories once a day and Celebrx, Bextra and Vioxx are one a day drugs.
They used to make Indocin suppositories -- very cheap and effective but they are off the market. Suppositories are an EXCELLENT drug delivery system, gettting more drug into the bloodstream, bypassing the GI system and breakdown in the liver. Why not used more? I don't know but it is a bit of a cultural 'thing' with Americans; Europeans don't seem to mind as much.
Ed

Re: Time to invest

Ed Davis, DPM on 9/30/04 at 15:13 (160781)

Richard:
It is a bit of a tough call. Merck does not have a lot of drugs in the 'pipeline' so they could be hurting for a while. They are one of the more conservative companies and tend to study their own drugs more than competitors study their own. Unless they know something that has yet to be divulged, they should simply reintroduce the drug labelling for short term usage, say 6 months at a time to be as cautious as possible.

I think that investing in generic drug companies is probably the way to go because they have products that have been out for a long time with proven track records and are strongly favored by third parties that are paying much of the bills. Just do your homework to find out which generic drug manufacturers have the best 'line up' of products.
Ed

Re: Vioxx has been voluntarily withdrawn

Carole C in NOLA on 9/30/04 at 18:19 (160792)

Kathy, when I first read the news about Vioxx, I thought of you and wondered what your next step will be.

I have a friend with R.A. who tried Celebrex twice and it did nothing good for him at all. Then a couple of years later, he tried it and it worked like a charm. So, it might be worth trying it again, if you haven't in the past few years. I got a lot of good pain relief from it for a couple of years.

I have to admit that I stopped taking it in 2002 (or was it 2003?) when I started hearing bad things about Vioxx. I thought, 'If Vioxx is dangerous, maybe Celebrex is too?' and quit taking it. Its effectiveness for me had diminished anyway. Also my pain had diminished a lot by that time. Now I usually don't medicate at all, or take Aleve once every month or two on an especially painful day.

But in your case, Kathy, I believe you to be in a great deal more pain than me due to a myriad of physical problems. I'm concerned for you I hope you can find something satisfactory to replace your Vioxx.

Carole

Re: Vioxx has been voluntarily withdrawn

Kathy G on 10/01/04 at 09:25 (160822)

Thanks for the concern, Carole. You're so thoughtful. I have decided to wait until next week and then I'll call the doctor and see if he will let me try Celebrex again. As I've said, I have reservations about that, too. I wonder if we're going to go through the same thing with it in a couple of years. And of course, I don't know if I'll still get the headache from it.

Ed, I do take some of what you mentioned although I just went and took a fish oil capsule, which I haven't taken in ages because it repeats on me. I read in Consumer Reports that if you keep it in the freezer, it's less likely to cause that reaction. Even if it does repeat, it's better than having a heart attack! I've been taking an 81mg enteric coated aspirin at bedtime for years. Not sure if I could take more because of my GERD and the fact that I had an ulcer (prior to Vioxx). I even have my two children (twenty-three and thirty) take the aspirin as that is one thing that seems to be very clear-cut in the medical community.

I, too, was wondering if I could occasionally take the Vioxx without a problem. I don't know what to think and I don't think anyone in the medical community really knows what to do. In an article in the Boston Globe this morning, one expert from Mass General (I think) said that these people who suffered cardiovascular events were predisposed to them prior to going on the Vioxx. That said, shouldn't that have been taken into consideration? Maybe he's wrong; I haven't read that anywhere else but information seems to be filtering in slowly.

I have never tried the Bromelain although I do know Scott talks about it and I remember someone on these Boards took it. Maybe that would be an option.

Medical science is wonderful but as we make the advances that we do, we are more apt to run into problems like this. As with HRT, we sometimes have to weigh the risk/benefit ratio and decide what's right for us as individuals. Because they recently put my husband on Vioxx, and because we mail away for our prescriptions, we currently have over 180 Vioxx on hand. I can either return them to the company for a refund or I could take one every three days for quite some time. I think he can probably take Celebrex.

Bottom line is that as long as my doctor knows what I'm doing, even if he doesn't approve, it will be my decision. Given my ongoing problems with inflammation, I know that I have to treat it or it's going to cause more and more problems for me. My chiro doesn't call me the 'Queen of Inflammation' for nothing!

Whatever the case, it's a beautiful day and I'm going to take advantage of it and figure this will resolve itself one way or another.

Thanks for all the advice, Ed.

Re: Time to invest

Richard, C.Ped on 10/01/04 at 11:27 (160833)

You never know. Martha Stewarts went way down. When she was sentenced, it went way up again. Missed that boat!

Re: Merck press release

john h on 10/01/04 at 12:21 (160834)

Ed you can bet part of your last dollar that a lot of the Merck motivation comes from the trial lawyers who are probably already frothing at the mouth. I expect to see any day advertisments in our local paper from lawyers asking anyone who think they have been harmed by Vioxx to please contact them.

Re: Vioxx has been voluntarily withdrawn

Ed Davis, DPM on 10/01/04 at 14:38 (160838)

Kathy:
Try flax seed oil if fish oil agrees poorly with you.
Ed

Re: Vioxx has been voluntarily withdrawn

Suzanne D. on 10/01/04 at 16:39 (160849)

Kathy, I, too, hope that you can find something that will treat your inflammation without risking other problems. I know if the migraine medicine which I have taken for years was going to be pulled from the market, I would be more than a little upset. I feel for all those affected.

Suzanne :)

Re: Vioxx has been voluntarily withdrawn

marie on 10/01/04 at 18:57 (160855)

I was on this for a short period of time but took myself off when the first studies began to show problems with heart and stroke. since it runs in my family and I have a few of those issues I thought it would be wise. My docs tried to talk me out of it but I stood my ground.

marie

Re: Vioxx has been voluntarily withdrawn

john h on 10/01/04 at 19:14 (160856)

Kathy: The only thing that hurts worse than my feet is the Cubs. The Billy Goat Curse strikes againg. We had it in the bag and blew it this week even with Nomar. Oh! The pain!!Wait til next year?

Re: Vioxx has been voluntarily withdrawn

Pauline on 10/01/04 at 19:36 (160857)

I don't know the entire Vioxx story. Is it suppose to even have a bad effect on those like yourself who only took it for a short period of time?
Do you now alway have to be on guard because you took it or if you didn't have any problem for the time that you were on it can you just forget that you took it?

Re: Vioxx has been voluntarily withdrawn

Dr. Z on 10/01/04 at 21:53 (160868)

It is my understanding that this is specific for patients who took the drug for longer then 18 months. Merck pulled the drug instead of just a new labeling. Dr.Ed just answered why they did this.

Re: Vioxx has been voluntarily withdrawn

JudyS on 10/03/04 at 12:30 (160924)

Go Braves!

Re: Vioxx

wendyn on 10/04/04 at 13:18 (160958)

John, my mom was one of the first people on Vioxx here about 5 years ago. She had been taken off the regular nsaids (Arthrotec) because of GI bleeding. Almost the entire time she was on Vioxx she experience VERY high blood pressure. Even with medication, it was very difficult to control. The last year she was on it, I was regularly sending her links to articles that showed a direct connection btwn Vioxx and high blood pressure. Absolutely could not convince her to go off it though; she was convinced it was helping her pain substantially.

She finally went off about a year or two ago (it caused another GI bleed). And, suprise suprise, her blood pressure was completely normal within a few months!

Re: Vioxx

john h on 10/05/04 at 11:49 (161003)

Wendy my daughter has been on Vioxx for about a year. Celebrex gave her headaches. She is now looking for a replacement.

Re: Merck press release

Ed Davis, DPM on 10/06/04 at 15:14 (161059)

John:
I suspect that that plays a large role. The Merck rep came by to take back samples. He did not get them all -- I saved a few for when I personally get a backache or headache, but cannot give them to anyone else. I have talked to several docs, they are still scratching their heads on this one....
Ed

Re: Merck press release

Pauline on 10/06/04 at 15:18 (161060)

Just as long as your ticker is ok Dr. Ed. Don't take them if you have any heart problems. Pay it safe.

Re: Merck press release

john h on 10/06/04 at 18:47 (161069)

Ed: Let the lawsuits begin. Last night on FOX a lawyer had his client on and they were filling a class lawsuit aginst Merck accusing them of killing her 34 year old daughter. When asked how they knew it was the Vioxx that was responsible the answer was she was only 34 and should not have had a heart problem. Asked about her weight and other factors the only thing they would say is she weighed 180 lbs. Fact is we now have children as young as 5 with high blood pressure and already showing signs of cardio vascular disease. Sometimes we need to look into the mirror. Asked how much they were suing for they would not answer. I cannot count the number of young athletic type people who have just dropped dead from heart problems but surely here it must be the Vioxx as she was only 34. I suspect everyone who died from any heart problems and who took Vioxx will be suing. It is no wonder our drugs cost so much. Look at any drug you take and you will see an endless number of warnings as drug companies attempt to protect themselves. It really does not work however. We blame the bartenders when someone gets drunk, blame the carmaker when someone is driving 100 mph and wrecks, and sue all the Doctors when someone dies. Ultimately it is not the drug companies,car companies,etc who pay it is you the consumer.

Re: Vioxx has been voluntarily withdrawn

Ed Davis, DPM on 10/08/04 at 15:04 (161177)

Pauline and Dr. Z:
Actually, I have never run into a short term side effect with Vioxx but several with Celebrex. I cannot recall, in 23 years, a drug that I could actually say that about. I think that long term use was the issue. Of course, Vioxx was subjected to studies not found in some of the similar drugs so the question remains if the same study was applied to various drugs in that class, what the results would be.
Ed

Re: Vioxx has been voluntarily withdrawn

Kathy G on 10/09/04 at 10:27 (161205)

Even the study that triggered the removal of the drug from the market said that there were no side effects until after the drug had been taken for eighteen months. I agree, Ed, that short-term use should still be allowed. And I wouldn't be surprised to see the drug come back, under a new name and with different indications, in the next few years.

I have a friend who has fought terrible migraine headaches for the last twenty-five years. She just went on Vioxx and it has been a miracle. She's a teacher and this is the first time she's gone this far into the school year without a migraine. And now they've taken it off the market! She's beside herself. No high blood pressure, no family history of heart disease.... Her doctor switched her to Celebrex but I don't think taking it for migraine headaches is one of the indications. She also has arthritis so he's not prescribing it off label. I sure hope it works the same way for her but I have my doubts. That one little molecule difference between Vioxx and Celebrex seems to make a great deal of difference.

Re: Vioxx has been voluntarily withdrawn

Terri on 10/09/04 at 16:32 (161223)

Kathy,

On the news this morning, they stated Celebrex and Bextra may go next as they seem to have the same sort of side effects that Vioxx did. This was reported on GMA.

On a personal note, my boyfriend was on Vioxx for only 8 months and started having nosebleeds. His dr took him off of it just last month.

Re: Vioxx has been voluntarily withdrawn

john h on 10/10/04 at 10:18 (161239)

I counted 8 advertisements in this mornings Sunday paper placed by lawyers asking anyone who took Vioxx to contact them. There are also major TV adds showing up on our local stations to contact various lawyers. Talk about a group of great white sharks circling these guy really smell the blood.

Re: Vioxx has been voluntarily withdrawn

Tracy on 10/22/04 at 14:54 (161995)

Be glad your boyfriend is off it. My husband last year was taking Vioxx had server Nosebleeds ending up in the hospital in trauma intensive care for nose bleeds had to be emblemize. I know this drug caused it after he was home a month he started to take the drug again with in three days his nose bleed called his doctor and told him that I thing vioxx is causing it he told me no I said I want him off it now. No nose bleeds seen. You have no idea how much pain and every thing he went throw with this. This pill does cause bleeding.

Re: Merck press release

carol s on 10/25/04 at 00:59 (162080)

Yes, let the law suits begin. I hope that I get at the top of the list. To think that I payed that company to give me medicine that probably (99% sure) caused of me to have a heart attack and congestive heart failure in 2000 and congestive heart failure again in 2001 and just about died with an ejection fraction in the low twentys. To top it all I was diganosed with ulcertive colonitis before I was taken off the medicine in 2002. I am on disability now because of constant angina of unknown cause and also suffer from vaso spasms and have to take nitro plus carry liquid nitro to use as needed. Yes, it is too bad they did not put warning labels, to try to protect them self or patients, on their medicine in 2000 when they first realized that it could cause heart problems or they of course could have put them on their labels, when warned by the FDA in 2001 and maybe alot of people would not have lost loved ones or been to hell and back with heart problems. You of course do realized that they spent 44 million on advertising for vioxx alone last year so they could make 2.55 billion last year on vioxx alone. Poor drug companies. I really have a hard time giving them any sympathy.

Re: Merck press release

Pauline on 10/25/04 at 08:13 (162091)

Carol,
I know you and others will get their day in court, I just don't know how anyone of you will be able to put a price on the illnesses resulting from taking this drug. A settlement will be provided and that's good, but unfortunately your health suffered greatly and there is not enough money in the world that will ever repair the damage already done.

Re: Merck press release

Dorothy on 10/25/04 at 15:38 (162128)

Carol S - I am really very sorry to read of what you have been through and are going through. I hope your heart and your health heal completely. Your bitter feelings are totally understandable, but I hope you can find ways to use your anger in ways that will help you. I am really sorry and hope that your body finds its way to good health.

What is amazing, too, is that the FDA approves these drugs that are then found to have these dangers - and not ten or twenty years down the road, but in a relatively short time. And recently we learned that the drug companies don't disclose significant aspects of their research, thereby skewing the evaluations. And then, add to that the thing that really gets my goat: the FDA is just straining at the bit (at the behest of Big Pharma) to prosecute and ban and criticize and fearmonger at every turn about 'natural' or 'alternative' products - while Big Pharma works its way on all of us.

You have my very best wishes and good thoughts and hopes that you will keep us posted about your progress.